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nkSRPS EN IEC 61326-2-6:2023/AA:2024

Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment

General information

30.99     Jul 11, 2025

40.10    Aug 7, 2025

ISS

N065

European Norm

17.220.20     25.040.40     33.100.20  

English  

Scope

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of IN VITRO
DIAGNOSTIC MEDICAL ELECTRICAL EQUIPMENT. This part of IEC 61326 applies to the BASIC SAFETY
and ESSENTIAL PERFORMANCE of IVD MEE in the presence of electromagnetic disturbances and to
electromagnetic disturbances emitted by IVD MEE.
BASIC SAFETY with regard to electromagnetic disturbances is applicable to all IVD MEE.
Note 1: performance with respect to electromagnetic disturbances other than ESSENTIAL PERFORMANCE is the subject of IEC 61326-1:2020
Note 2: IT equipment can be a part of an IVD MEE, if it is required to maintain BASIC SAFETY or ESSENTIAL PERFORMANCE

Related directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.

2017/746

Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU

Life cycle

PREVIOUSLY

PROJECT
dnaSRPS EN IEC 61326-2-6:2025

NOW

PROJECT
nkSRPS EN IEC 61326-2-6:2023/AA:2024
30.99 CD approved for registration as DIS
Jul 11, 2025

Related project

Adopted from EN IEC 61326-2-6:2025/prAA:2025 IDENTICAL